Healthcare Equipment and Supplies
Company Overview of NeuroPace, Inc.
NeuroPace, Inc. designs, develops, manufactures, and markets implantable devices for the treatment of neurological disorders by responsive brain stimulation. It offers RNS system that is designed for the treatment of medically refractory partial epilepsy, includes implantable and external products; implantable components, including depth leads and cortical strip leads; and RNS neurostimulator, a programmable, battery powered, and microprocessor-controlled device that delivers a short train of electrical pulses to the brain through implanted leads. The company was founded in 1997 and is based in Mountain View, California.
455 North Bernardo Avenue
Mountain View, CA 94043
Founded in 1997
Key Executives for NeuroPace, Inc.
Chief Financial Officer and Vice President of Finance & Administration
Vice President of Quality Assurance and Manufacturing Operations
Vice President of Regulatory Affairs
Compensation as of Fiscal Year 2014.
NeuroPace, Inc. Key Developments
NeuroPace, Inc. Announces Partnership with the Defense Advanced Research Projects Agency
Jul 22 14
NeuroPace, Inc. announced its partnership with the Defense Advanced Research Projects Agency (DARPA) Restoring Active Memory (RAM) teams at the University of Pennsylvania and the University of California, Los Angeles (UCLA) to develop new treatments for memory deficits using neurostimulation. The RNS(R) System is the world's only commercially available implantable closed-loop responsive neurostimulator system. NeuroPace received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for the RNS System in November 2013. It is approved as a treatment for adults with partial onset seizures with one or two seizure onset zones whose seizures have not been controlled with two or more antiepileptic drugs. Through the DARPA RAM research, NeuroPace and other collaborators will gain fundamental knowledge regarding the restoration of memory. The company believes this research may expand the clinical applications of the RNS System beyond the treatment of epilepsy, as well as provide the understanding necessary to inform the development of future devices that expand the capabilities of responsive neurostimulation. This collaborative effort will advance the field of brain research and closed-loop neurostimulation applications.
FDA Grants Premarket Approval for the NeuroPace, Inc.'s RNS System to Treat Medically Refractory Epilepsy
Nov 14 13
NeuroPace, Inc. announced that the U.S. Food and Drug Administration has granted premarket approval for the NeuroPace(R) RNS(R) System, a treatment for adults with partial onset seizures that have not been controlled with two or more antiepileptic drugs. The RNS System is a novel, implantable therapeutic device that delivers responsive neurostimulation, an advanced technology designed to detect abnormal electrical activity in the brain and respond by delivering imperceptible levels of electrical stimulation to normalize brain activity before an individual experiences seizures. The RNS(R) System has been granted premarket approval (PMA) from the FDA for the treatment of adults with partial onset seizures that have not been controlled with two or more antiepileptic drugs. The RNS System is a novel, implantable therapeutic device that delivers responsive neurostimulation, an advanced technology designed to detect abnormal electrical activity in the brain and respond by delivering imperceptible levels of electrical stimulation to normalize brain activity before an individual experiences seizures. The RNS System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localized no more than two epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures (motor partial seizures, complex partial seizures and/or secondarily generalized seizures). The RNS System has demonstrated safety and effectiveness in patients who average three or more disabling seizures per month over the three most recent months (with no month with fewer than two seizures), and has not been evaluated in patients with less frequent seizures. It is estimated that approximately 400,000 people in the U.S. meet these criteria and may benefit from treatment with the RNS System. The RNS System has been evaluated in three clinical trials, including a prospective, randomized, double-blinded, sham stimulation controlled pivotal study. The pivotal study primary effectiveness endpoint was met by demonstrating a 37.9% reduction in seizure frequency in patients treated with responsive stimulation compared to a 17.3% reduction in patients who were implanted with the device but were not receiving responsive stimulation during a three month blinded period. The difference is statistically significant (p=0.012). For those subjects who reached two years post-implant, 55% of the subjects experienced a 50% or greater reduction in seizures. The pivotal trial primary safety endpoint was met by demonstrating a serious adverse event rate for the first 4 and 12 weeks post-implant comparable to similar procedures. There was no difference between the active and sham stimulation groups in the rate of adverse events, including depression, memory impairment and anxiety. There were no serious unanticipated device related adverse events reported in any of the clinical trials. Although there can be no assurances that additional long-term data will not reveal new adverse information presently unknown to NeuroPace, two year data shows no increase or worsening of adverse events. A total of 256 patients have been implanted with the RNS System. At this time, some patients have been treated with the RNS System for over eight years, and more than 1,200 patient years of experience with responsive neurostimulation have been accumulated to date.
FDA Advisory Panel Recommends Approval of the NeuroPace, Inc.'s NeuroPace RNS(R) System for Medically Refractory Epilepsy
Feb 26 13
NeuroPace, Inc. announced that on February 22, 2013 the U.S. Food and Drug Administration (FDA) Neurological Devices Panel voted unanimously (11 to 0 with two abstentions) that the clinical benefits of the NeuroPace RNS System outweigh the risks of its use. NeuroPace is seeking approval for the RNS System for treating adults with partial onset seizures that have not been controlled with two or more antiepileptic medications. The final decision regarding approval of the device is made by the FDA. The RNS System has been evaluated in three clinical trials, including the prospective, randomized, double blinded, sham-stimulation controlled pivotal study. The pivotal study primary effectiveness endpoint was met by demonstrating a 37.9% reduction in seizure frequency in the treatment group compared to a 17.3% reduction in the sham-stimulation control group during a three month blinded evaluation period. This difference was statistically significant (p=0.012). Long-term results demonstrated sustained improvements in seizure frequency with median seizure frequency reductions of 44% and 53% at one and two years post-implant, respectively.
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